Associate Clinical Pbpk Modeler, Clinical
hace 2 semanas
**Typical Accountabilities**
- Utilize physiologically-based pharmacokinetic (PBPK) and translational modeling tools to enable clinical PK projections for drug-drug interactions (DDIs), pediatric and other specific populations, and other clinical development questions
- Collaborate with Drug Metabolism and Pharmacokinetic (DMPK) Scientists and Clinical Pharmacology scientists to generate these mechanistic models
- Validate the mechanistic models to the level of being able to be used in Regulatory submissions and to influence the design of clinical trials
- Communicate clearly and effectively both internally and externally on topics related to PBPK clinical DDI and pediatric and other specific populations predictions
- Keep up to date with emerging literature, modeling science, and regulatory expectations
**Education, Qualifications, Skills and Experience**
- Knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
- Demonstrated broad translational development expertise and experience exemplified by 0-4 Years of drug development experience, with emphasis on PBPK modelling
- Good knowledge in pharmacology, drug targets and core disease areas
- Demonstrated ability to identify, develop and execute PBPK activities at a project level
- Good oral and written communication skills
- Good knowledge of global regulatory, compliance, processes, standards and issues specific to PBPK
- PhD degree with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PBPK and other relevant software (e.g., SimCYP, GastroPlus, PK-Sim, Phoenix WinNonlin)
- Fluency in spoken and written English language
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